Identifiers
- 510(k) Number
- K831229 FDA 510(k)
- FDA Product Code
- FHJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4530 FDA 510(k)
- Regulation Number
- 884.4530 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Super Snaps is a shield for circumcision used in obstetrics and gynecology procedures. It is a medical device classified as Class II under FDA regulations.
The device was cleared through the FDA 510(k) process with K-number K831229 and is substantially equivalent to a predicate device. It is supplied non-sterile and intended for single-use in clinical settings.
Frequently asked questions
What is Super Snaps used for?
Super Snaps is a shield designed for use in circumcision procedures within obstetrics and gynecology settings, providing protection during the surgical process as indicated in its FDA 510(k) clearance.
Is Super Snaps sterile or non-sterile when supplied?
Super Snaps is supplied non-sterile, as specified in the device data, and is intended for single-use only in clinical environments where appropriate sterilization can be performed prior to use.
Can Super Snaps be reused after a procedure?
No, Super Snaps is intended for single-use only, as stated in the device description, to prevent cross-contamination and ensure patient safety in accordance with its design and clearance.
What regulatory pathway was used for Super Snaps?
Super Snaps received market authorization through the FDA 510(k) traditional clearance process under K-number K831229, demonstrating substantial equivalence to a legally marketed predicate device.
What is the device classification of Super Snaps?
Super Snaps is classified as a Class II medical device by the FDA, as indicated in the device data, which reflects its risk level and the regulatory controls required for its market clearance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Super-Snap - Shofu Dental, Super-Snap - Shofu USA, Super-Snap® Singles, Standard and Mini - Shofu USA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831229 | Class II | Active |
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Manufacturer
- Manufacturer
- Shofu Dental Corp.
Sources (1)
- FDA 510(k) K831229 24 fields · synced Sep 21, 2026